JP6973456B2 - 癌化学療法時の副作用軽減剤 - Google Patents
癌化学療法時の副作用軽減剤 Download PDFInfo
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- JP6973456B2 JP6973456B2 JP2019161514A JP2019161514A JP6973456B2 JP 6973456 B2 JP6973456 B2 JP 6973456B2 JP 2019161514 A JP2019161514 A JP 2019161514A JP 2019161514 A JP2019161514 A JP 2019161514A JP 6973456 B2 JP6973456 B2 JP 6973456B2
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- cancer
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- cystine
- theanine
- chemotherapy
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Description
即ち、本発明は以下の通りである。
[2](A)シスチン又はその誘導体と、(B)テアニンとを含有する組成物である、上記[1]記載の剤。
[3](A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、上記[1]又は[2]記載の剤。
[4]癌化学療法の治療完遂率改善剤である、上記[1]〜[3]のいずれか1つに記載の剤。
[5]上記[1]〜[3]のいずれか1つに記載の剤と、抗癌剤とを組み合わせてなる、癌の予防及び/又は治療薬。
[6](A)シスチン又はその誘導体と、(B)テアニンとを組み合わせてなる、癌化学療法の治療完遂率改善剤。
[7](A)シスチン又はその誘導体と、(B)テアニンとを含有する組成物である、上記[6]記載の剤。
[8](A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、上記[6]又は[7]記載の剤。
[9](A)シスチン又はその誘導体と、(B)テアニンと、抗癌剤とを組み合わせてなる、癌の予防及び/又は治療薬。
[10](A)シスチン又はその誘導体と、(B)テアニンとを含有する組成物と、抗癌剤とを組み合わせてなる、上記[9]記載の予防及び/又は治療薬。
[11](A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、上記[9]又は[10]記載の予防及び/又は治療薬。
[12]上記[1]〜[3]のいずれか1つに記載の剤を、それを必要とする対象に投与することを含む、癌化学療法時の副作用軽減方法。
[13](A)シスチン又はその誘導体、並びに(B)テアニンの有効量を、それを必要とする対象に投与することを含む、癌化学療法時の副作用軽減方法。
[14](A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、上記[13]記載の方法。
[15]上記[4]及び[6]〜[8]のいずれか1つに記載の剤を、それを必要とする対象に投与することを含む、癌化学療法の治療完遂率改善方法。
[16](A)シスチン又はその誘導体、並びに(B)テアニンの有効量を、それを必要とする対象に投与することを含む、癌化学療法の治療完遂率改善方法。
[17](A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、上記[16]記載の方法。
[18]上記[5]及び[9]〜[11]のいずれか1つに記載の予防及び/又は治療薬を、それを必要とする対象に投与することを含む、癌の予防及び/又は治療方法。
[19](A)シスチン又はその誘導体、(B)テアニン、並びに抗癌剤の有効量を、それを必要とする対象に投与することを含む、癌の予防及び/又は治療方法。
[20](A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、上記[19]記載の方法。
[21]癌化学療法時の副作用軽減における使用のための、(A)シスチン又はその誘導体と(B)テアニンとの組み合わせ。
[22]癌化学療法の治療完遂率改善における使用のための、上記[21]記載の組み合わせ。
[23]癌化学療法の治療完遂率改善における使用のための、(A)シスチン又はその誘導体と(B)テアニンとの組み合わせ。
[24]癌の予防及び/又は治療における使用のための、上記[21]記載の組み合わせと抗癌剤との組み合わせ。
[25]癌の予防及び/又は治療における使用のための、(A)シスチン又はその誘導体と(B)テアニンと抗癌剤との組み合わせ。
[26](A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、上記[21]〜[25]のいずれか1つに記載の組み合わせ。
[27]上記[1]〜[4]及び[6]〜[8]のいずれか1つに記載の剤を製造するための、(A)シスチン又はその誘導体と(B)テアニンの使用。
[28]上記[5]及び[9]〜[11]のいずれか1つに記載の予防及び/又は治療薬を製造するための、(A)シスチン又はその誘導体と(B)テアニンと抗癌剤の使用。
また本発明によれば、癌化学療法の治療完遂率改善剤、並びに、癌の予防及び/又は治療剤を提供できる。
本発明の癌化学療法時の副作用軽減剤は、(A)シスチン又はその誘導体と、(B)テアニンとを組み合わせてなることを主たる特徴とする。
本明細書において、本発明の癌化学療法時の副作用軽減剤を、便宜上「本発明の剤」とも称する。
本発明の剤の成分Aは、シスチン又はその誘導体である。
本発明の剤の成分Bは、テアニンである。
なお、成分Aと成分Bとを時間差をおいて摂取する場合、両者が体内で共存することが好ましい。
本発明の剤が、成分Aを含有する第1組成物と、成分Bを含有する第2組成物とを組み合わせて用いるものである場合、これらの組成物の剤形は、同一であってもよいし、異なってもよい。
本発明の剤が、成分Aを含有する第1組成物と、成分Bを含有する第2組成物とを組み合わせて用いるものである場合、これらの組成物が含有する製剤用物質は、同一であってもよいし、異なってもよい。
本発明の剤は、癌化学療法の休止の原因となり得る副作用を軽減し得るため、癌化学療法の治療完遂率改善剤として用いられ得る。
本発明の剤は、代謝拮抗剤(より好ましくはピリミジン代謝拮抗剤、特に好ましくは5FU、テガフール・ギメラシル・オテラシルカリウム)を用いる癌化学療法の治療完遂率を改善するために好ましく用いられ得る。
本発明は、副作用(好ましくは、癌化学療法の休止の原因となり得る副作用)が軽減された癌の予防及び/又は治療薬も提供する。本発明の癌の予防及び/又は治療薬は、本発明の剤と、抗癌剤とを組み合わせてなることを主たる特徴とする。
本明細書において、本発明の癌の予防及び/又は治療薬を、便宜上「本発明の予防及び/又は治療薬」とも称する。
本発明の予防及び/又は治療薬は、本発明の剤と抗癌剤とを同時に投与してもよい。
本発明の予防及び/又は治療薬が、本発明の剤と抗癌剤とを別個の製剤とするものである場合、これらの製剤の剤形は、同一であってもよいし、異なってもよい。
本発明の予防及び/又は治療薬が、本発明の剤と抗癌剤とを別個の製剤とするものである場合、これらの製剤が含有する製剤用物質は、同一であってもよいし、異なってもよい。
L−シスチン2,625g、L−テアニン1,050g、デキストリン1,710g、アスパルテーム15gを混合した後、結晶セルロース1,500g及び重量比で30%の70%エタノールを加えて練合し、押し出し造粒した。得られた造粒物は、含水率1.6%以下まで乾燥後整粒し、16メッシュPASSの粒子を得た後、微粒二酸化ケイ素37.5g、グリセリン脂肪酸エステル487.5g及びワニラ香料75gを加え混合した。得られた混合物は、11mmΦ、500mg、打錠圧力2.0ton、回転数20rpm、硬度平均10kgの条件で打錠した。以上の操作で、1錠あたり175mgのL−シスチン及び70mgのL−テアニンを含有する直径11mmの錠剤(全量:425mg)を製造した。
多剤併用の癌化学療法が行われ、副作用として口内炎が発症した患者14名を、本試験の対象とした。該患者の疾患は、直腸癌、結腸癌、胃癌又は乳癌であった。該患者は、癌の種類及び進行ステージに対応したレジメンに基づき、多剤併用の癌化学療法が行われ、CTCAE v4.0にて口内炎の発症が確認された時点から1箇月間、シスチン及びテアニン含有サプリメント(L−シスチンとして700mg、L−テアニンとして280mg、サプリメントの総量として1.7g)を1日1回摂取させた。摂取開始から1箇月後、口内炎の状態をCTCAE v4.0のグレード分類を用いて評価した。また、口内炎の状態及び痛みについて、患者自身による主観評価を実施した。当該主観評価の評価基準は、下記の通りである。
1:治った。又は、できなくなった。
2:完治しないが、良くなった。
3:変わりなし。
4:やや悪化した。
5:かなり悪化した。
1:なくなった。
2:なくならないが、良くなった。
3:変わりなし。
4:ややひどくなった。
5:かなりひどくなった。
「FOLFOX+BV>Cmab+CPT11」は、当初はFOLFOX+BVを投与し、その後、これに代えてCmab+CPT11を投与したことを意味する。同様に、「HPT+DTX>HPT+S1」は、当初はHPT+DTXを投与し、その後、これに代えてHPT+S1を投与したことを意味する。
これらの結果から、多剤併用の癌化学療法の開始後に口内炎を発症した患者に対して、シスチン及びテアニン含有サプリメントを摂取させることにより、口内炎が改善したことが明らかとなった。
大腸癌又は胃癌の術後補助化学療法として、外科手術から6週間以内に、テガフール・ギメラシル・オテラシルカリウム配合剤(商品名:TS−1)の投与が予定されている患者を、本試験の対象とした。対象患者は、封筒法にて、シスチン及びテアニンを摂取させる群(シスチン及びテアニン摂取群)と、シスチン及びテアニンを摂取させない群(対照群)との2群に分けた。本試験においてテガフール・ギメラシル・オテラシルカリウム配合剤の用量は、患者の体表面積が1.25m2未満の場合はテガフール相当量で80mg/dayとし、該体表面積が1.25m2以上〜1.5m2未満の場合はテガフール相当量で100mg/dayとし、該体表面積が1.5m2以上の場合はテガフール相当量で120mg/dayとした。また、該用量は各患者の腎機能(クレアチニンクリアランス)に応じて適宜調整した。テガフール・ギメラシル・オテラシルカリウム配合剤の投与スケジュールは、テガフール・ギメラシル・オテラシルカリウム配合剤を1日2回、4週間連日経口投与した後、2週間休薬し、これを1クールとして投与を繰り返した。シスチン及びテアニン摂取群は、テガフール・ギメラシル・オテラシルカリウム配合剤の投与開始の1週間前から連続5週間(テガフール・ギメラシル・オテラシルカリウム配合剤投与1クール目の4週間を含む)、シスチン及びテアニン含有サプリメント(L−シスチンとして700mg、L−テアニンとして280mg、サプリメントの総量として1.7g)を、1日1回朝に、少量の水とともに摂取した。対照群は、シスチン及びテアニン含有サプリメントを摂取せず、テガフール・ギメラシル・オテラシルカリウム配合剤のみを摂取した。両群とも、試験終了までは、サプリメント類及びビタミン類の服用を禁止した。テガフール・ギメラシル・オテラシルカリウム配合剤の投与前、投与開始から1週間後、2週間後、4週間後及び6週間後に、採血及び副作用の症状(食欲不振、悪心、下痢及び倦怠感)の聴取を実施した。採血結果、副作用の発生状況及び重症度は、CTCAE v4.0のグレード分類を用いて評価した。CTCAE v4.0のグレード分類による評価において、血中の顆粒球数、食欲不振、悪心、下痢及び倦怠感のいずれかがグレード2以上であった患者は、テガフール・ギメラシル・オテラシルカリウム配合剤の投与を休止した。図1に、試験スケジュールを図示する。
結果を図2及び図3に示す。
当該結果から、シスチン及びテアニン含有サプリメントの摂取により、テガフール・ギメラシル・オテラシルカリウム配合剤投与に伴う顆粒球減少が軽減したことが明らかとなった。
結果を図4及び図5に示す。
従って、当該結果からも、シスチン及びテアニン含有サプリメントの摂取により、テガフール・ギメラシル・オテラシルカリウム配合剤投与に伴う顆粒球減少が軽減したことが確認された。
結果を図6に示す。
当該結果から、シスチン及びテアニン含有サプリメントの摂取により、テガフール・ギメラシル・オテラシルカリウム配合剤投与に伴う顆粒球減少、食欲不振、悪心、下痢及び倦怠感の発症が軽減したことが明らかとなった。
結果を図7及び図8に示す。
当該結果から、シスチン及びテアニン含有サプリメントの摂取により、テガフール・ギメラシル・オテラシルカリウム配合剤投与に伴う顆粒球減少、口内炎、食欲不振、悪心、下痢、倦怠感及び皮疹の発症が軽減したことが明らかとなった。
結果を表2及び図9に示す。
当該結果から、シスチン及びテアニン含有サプリメントの摂取により、テガフール・ギメラシル・オテラシルカリウム配合剤投与に伴う各種副作用が軽減し、癌化学療法の治療完遂率が改善したことが明らかとなった。
結果を表3及び図10に示す。
従って、当該結果からも、シスチン及びテアニン含有サプリメントの摂取により、テガフール・ギメラシル・オテラシルカリウム配合剤投与に伴う各種副作用が軽減し、癌化学療法の治療完遂率が改善したことが確認された。
結果を図11に示す。
当該結果から、シスチン及びテアニン含有サプリメントの摂取により、テガフール・ギメラシル・オテラシルカリウム配合剤投与に伴う各種副作用が軽減し、該配合剤の全用量を、より長期間服薬できるようになったことが明らかとなった。
また本発明によれば、癌化学療法の治療完遂率改善剤、並びに、癌の予防及び/又は治療剤を提供できる。
Claims (3)
- (A)シスチン又はその誘導体と、(B)テアニンとを組み合わせてなる、癌化学療法時の副作用軽減剤(ただし、癌化学療法の治療完遂率改善剤でない)であって、
癌化学療法時の副作用が、口内炎、食欲不振、悪心、嘔吐、下痢、倦怠感及び皮疹からなる群より選択される少なくとも一つであり、
シスチンの誘導体が、グルタチオン、グルタチオンジスルフィド、グルタチオンアルキルエステル、酸化型グルタチオンジアルキルエステル、システイン、システインアルキルエステル、3−[(カルボキシメチル)チオ]アラニン、N−アシルシステイン、N−アシルシステインアルキルエステル、N−アシルシスチン、N−アシルシスチンアルキルエステル、N,N’−ジアシルシスチン、N,N’−ジアシルシスチンジアルキルエステル及びS−アルキルシステインスルフォキシドからなる群より選択される、剤。 - (A)シスチン又はその誘導体と、(B)テアニンとを含有する組成物である、請求項1記載の剤。
- (A)シスチン又はその誘導体と(B)テアニンとの重量比が、A:B=100:1〜1:100である、請求項1又は2記載の剤。
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2014
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2016
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EP3028696A4 (en) | 2017-01-25 |
US20160143871A1 (en) | 2016-05-26 |
JP2019203025A (ja) | 2019-11-28 |
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CN105392478A (zh) | 2016-03-09 |
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JPWO2015015989A1 (ja) | 2017-03-02 |
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